The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from J&J, Pfizer, BioNTech, Fosun, Sinovac, Sinopharm, and the FDA.
Manufacturing and supply of COVID-19 vaccines and drugs
FDA OKs Additional Batch of J&J’s COVID-19...
A roundup of news from China (Sparx Therapeutics), France (Sanofi), the UK (Pfizer, AbbVie, and Biogen) and the US (GSK, Nkarta, and USP).
China
Sparx Therapeutics To Build for Antibody Drug Mfg FacilitySparx Therapeutics, a Chicago-based...
The UK Competition and Markets Authority has cleared AstraZeneca’s proposed $39-billion acquisition of Alexion Pharmaceuticals, a Boston-based bio/pharmaceutical company focused on rare diseases. The clearance follows competition clearances in the...
Eli Lilly and Company has acquired Protomer Technologies, a Pasadena, California-based technology company specializing in engineering protein therapeutics, in a $1-billion deal (inclusive of undisclosed milestone payments). Lilly currently holds a...
Novo Nordisk has agreed to acquire from Prothena, a Dublin, Ireland-based bio/pharmaceutical company, PRX004, an anti-amyloid immunotherapy, and Prothena’s broader ATTR amyloidosis program, in a $1.2-billion deal ($100 million upfront and...
The Pharmaceutical Inspection Co-operation Scheme (PIC/S), a non-binding, informal co-operative arrangement between regulatory authorities in the field of good manufacturing practice (GMP) of medicinal products for human or veterinary use, has...
The latest on COVID-19 vaccines/drugs and manufacturing from Moderna and J&J.
Manufacturing and supply of COVID-19 vaccines and drugs
Recipharm Site Approved for Mfg of Moderna’s COVID-19 Vaccine Recipharm, a CDMO of active pharmaceutical...
A roundup of news from Germany (CureVac, Merck KGaA), Israel (Teva, Bioeq), the UK (GSK), and the US (J&J, Viatris, Sanofi, Teva, MacroGenics, and Senti Biosciences).
Germany
Merck KGaA, BioMed X Launch Oncology Research ProgramMerck KGaA and...
Novartis has resubmitted to the US Food and Drug Administration (FDA) its new drug application (NDA) for inclisiran, a potential blockbuster drug for treating certain types of high cholesterol, to reflect a change to the manufacturing site for the...
GlaxoSmithKline (GSK) and Alector, a South San Francisco, California-based clinical-stage bio/pharmaceutical company, have entered into a pact to co-develop monoclonal antibodies (mAbs) for a range of neurodegenerative diseases, in a deal worth up...
The European Commission (EC) has approved AstraZeneca’s proposed $39-billion acquisition of Alexion Pharmaceuticals, a Boston-based bio/pharmaceutical company focused on rare diseases.
The clearance follows competition clearances in the US, Japan,...
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Moderna, AstraZeneca, Roche, J&J, Pfizer, Novavax, CureVac, Sinovac, and Thermo Fisher.
Manufacturing and supply of COVID-19 vaccines and drugs
EMA OKs Additional Mfg...
The US Food and Drug Administration (FDA) has issued its annual report on drug shortages by outlining the extent of drug shortages in calendar year 2020 and the steps the agency has taken to mitigate shortages, including those relating to the...
Sanofi has launched a dedicated mRNA Center of Excellence with a planned annual commitment of approximately EUR 400 million ($475 million) to develop and deliver mRNA vaccines.
The center will bring together approximately 400 employees by...
Sanofi has agreed to sell a portfolio of 16 local and regional consumer healthcare brands in countries predominantly in Europe to Stada, a Bad Vilbel, Germany-based specialty pharma, generics, and non-prescription consumer healthcare company, for...
